Charlottesville, Virginia 22908


Purpose:

The purpose of this project is to evaluate the safety, efficacy, and feasibility of performing prostatic artery embolization (PAE) using endovascular techniques and particle embolics in men suffering from lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH).


Study summary:

This pilot study is a prospective, non-randomized clinical trial assessing the safety and feasibility of prostatic artery embolization. Fifty adult male subjects will be enrolled and treated in this study. Patients who provide informed consent and are deemed eligible for participation will undergo prostatic artery embolization in the Interventional Radiology department at the University of Virginia. After performing an angiogram to identify the prostatic arteries, tiny particles known as Embozene Microspheres will be injected into the prostatic artery. Injecting these particles into the prostatic artery will slow blood flow to the prostate and thus shrinking the size of the prostate. By shrinking the size of the prostate, it is hopeful that it will provide relief of lower urinary tract symptoms due to BPH. Subjects will be followed for 2 years as part of their participation in this study.


Criteria:

Inclusion Criteria: - Patients between ages 45-80 years - Diagnosis of Lower Urinary Tract Symptoms from Benign Prostatic Hypertrophy for a minimum of 6 months - IPSS score at initial evaluation should be greater than 7, and uroflowmetry (Qmax) of <12mL/s (milliliters per second) . - All prostate volumes will be at least 40gm and no more than 400gm based on DRE, TRUS, or cross sectional imaging Exclusion Criteria: - Patients with urinary tract infections (> 2/year), prostatitis, or interstitial cystitis - Cases of biopsy proven prostate cancer or urethral cancer. - Patients on long-term narcotic analgesia, androgen therapy, or GNRH (gonadotropin-releasing hormone) analogue therapy within 2 months of study. - Patients who are classified as New York Heart Association Class III (Moderate), or higher. - Patients with history of prior pelvic irradiation. - Hypersensitivity reactions to contrast material not manageable with prophylaxis. - Patients with serum creatinine values >1.7mg/dl or glomerular filtration rates less than 50.


NCT ID:

NCT02592473


Primary Contact:

Principal Investigator
Ziv J Haskal, MD
Professor of Radiology

Joshua Feazell, BS
Phone: 434-297-5682
Email: JF9RF@virginia.edu


Backup Contact:

Email: bjk3c@virginia.edu
Brigitte J Kelly, BSN RN CCRC
Phone: 434-297-7136


Location Contact:

Charlottesville, Virginia 22908
United States

Joshua Feazell, BS
Phone: 434-297-5682
Email: jf9rf@virginia.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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